Axoprofen Forte

Leaflet accompanying the packaging: information for the user

Axoprofen Forte, 40 mg/ml, oral suspension

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If:
• after 24 hours (if the child is under 6 months old)
• after 3 days (if the patient is over 6 months old) there is no improvement or the patient feels worse, consult a doctor.

Table of contents of the leaflet

• 1. What is Axoprofen Forte and what is it used for
• 2. Important information before taking Axoprofen Forte
• 3. How to take Axoprofen Forte
• 4. Possible side effects
• 5. How to store Axoprofen Forte
• 6. Contents of the packaging and other information

1. What is Axoprofen Forte and what is it used for

Axoprofen Forte contains ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by reducing pain, inflammation, and fever.

Axoprofen Forte is used in the following cases:

• fever of various origins (also in the course of viral infections, in the course of post-vaccination reactions)
• pains of various origins of mild to moderate severity, such as:
• headaches, throat and muscle pains, e.g. in the course of viral infections
• muscle, joint and bone pains, as a result of injuries to the musculoskeletal system (sprains, strains)
• pains due to soft tissue injuries, post-operative pains
• pains due to teething, toothaches, pains after dental procedures
• headaches (including migraines)
• ear pains occurring in middle ear inflammatory conditions.

2. Important information before taking Axoprofen Forte

When not to take Axoprofen Forte:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other nonsteroidal anti-inflammatory drugs (NSAIDs)
• if the patient has ever had a hypersensitivity reaction, such as: asthma, rhinitis, itchy skin rash or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs)
• if the patient has bleeding disorders
• if the patient has or has had stomach or duodenal ulcer, with perforation or bleeding, or if the patient has had two or more such episodes in the past
• if the patient has had bleeding or perforation of the gastrointestinal tract, associated with previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) (the child may have vomit containing blood or dark particles resembling coffee grounds or black, tarry stools containing blood)
• if the patient has an increased tendency to bleeding or problems with the production of certain blood components (such as platelet deficiency - thrombocytopenia)
• if the patient has severe liver, kidney or heart failure
• if the patient is in the third trimester of pregnancy
• if the patient is dehydrated
• if the child weighs less than 5 kg and is under 3 months old
• if the patient has hemophilia.

Warnings and precautions

Before starting treatment with Axoprofen Forte, discuss it with your doctor, pharmacist, or nurse.

This is especially important:

• if the patient has systemic lupus erythematosus and mixed connective tissue disease
• if the patient has gastrointestinal diseases and chronic inflammatory bowel diseases, such as Crohn's disease or ulcerative colitis
• if the patient has hypertension and/or heart failure
• if the patient has kidney or liver dysfunction
• if the patient has bleeding disorders or is taking anticoagulant medications
• if the patient has or has had asthma or other allergic diseases
• if the patient is dehydrated (especially in children and adolescents), as there is a risk of kidney failure
• if the patient has symptoms of allergic reactions after taking acetylsalicylic acid
• if the patient has chickenpox
• if the patient has an infection - see below, section entitled "Infections".

During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), chest pain.

In case of any of these symptoms, stop taking Axoprofen Forte and contact your doctor or emergency medical services immediately.

Skin reactions

Severe skin reactions have occurred with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).

If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, stop taking Axoprofen Forte and seek medical attention.

Infections

Like other anti-inflammatory medicines, Axoprofen Forte may mask the symptoms of infection, such as fever, pain, swelling.

As a result, Axoprofen Forte may delay the use of appropriate infection treatment, leading to an increased risk of complications.

This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox.

If the patient is taking this medicine during an ongoing infection, and the symptoms of the infection persist or worsen, consult a doctor immediately.

Taking pain-relieving and anti-inflammatory medicines, such as Axoprofen Forte, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses.

Do not exceed the recommended dose or duration of treatment (see section 3).

During long-term treatment with high doses of pain-relieving medicines, headaches may occur that should not be treated with increased doses of medicines.

In general, habitual use of pain-relieving medicines, especially in combination with other pain-relieving medicines, may cause permanent kidney damage and increase the risk of kidney failure.

Before taking Axoprofen Forte, the patient should consult a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, bypass surgery, the patient has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has high blood pressure, diabetes, high cholesterol levels, there is a history of heart disease or stroke in the patient's family, or if the patient smokes.

Axoprofen Forte may cause vision disturbances (blind spots, color vision disturbances).

In such cases, stop taking the medicine and have an eye examination.

Axoprofen Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

This is especially important if you are taking:

• other medicines containing ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs), including those available without a prescription
• acetylsalicylic acid (aspirin) used to prevent heart attacks and strokes - after taking ibuprofen, protection may be reduced
• anticoagulant medicines (e.g. warfarin)
• antiplatelet agents (e.g. dipyridamole, clopidogrel)
• mifepristone (used for medical termination of pregnancy)
• zidovudine (used to treat HIV)
• sulfonylurea derivatives, such as glibenclamide (used to treat diabetes)
• methotrexate (used to treat psoriasis, arthritis, and certain types of cancer)
• cardiac glycosides (e.g. digoxin used to treat certain heart conditions)
• phenytoin (an antiepileptic medicine), as ibuprofen may increase the levels of this medicine in the blood
• diuretics
• antihypertensive medicines (e.g. ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)
• corticosteroids (anti-inflammatory medicines)
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression
• aminoglycoside antibiotics (used to treat infections)
• lithium (used to treat mood disorders)
• cyclosporine or tacrolimus (used to prevent transplant rejection)
• cholestyramine (used to lower cholesterol levels)
• voriconazole or fluconazole (types of antifungal medicines)
• probenecid and sulfinpyrazone (used to treat gout)
• baclofen (a medicine that reduces muscle tension)
• ritonavir (a medicine used to treat HIV)
• products containing Ginkgo biloba, as they may increase the risk of bleeding.

If you are unsure about any of the above situations, consult your doctor or pharmacist before taking the medicine.

If you or your caregiver are unsure what types of medicines you are taking, show them to your doctor or pharmacist.

Axoprofen Forte may affect the action of other medicines or other medicines may affect the action of Axoprofen Forte.

For example:

• medicines with anticoagulant action (i.e. blood thinners, preventing blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Also, some other medicines may be affected or have an effect on treatment with Axoprofen Forte.

Therefore, before taking Axoprofen Forte with other medicines, always consult your doctor or pharmacist.

Axoprofen Forte with food, drink, and alcohol

The medicine should be taken preferably after a meal.

Avoid consuming alcohol while taking Axoprofen Forte, as it may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

DO NOTtake Axoprofen Forte in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery.

Axoprofen Forte may cause kidney and heart problems in the unborn baby.

It may also increase the risk of bleeding in the mother and her baby and cause delayed or prolonged labor.

In the first 6 months of pregnancy, the patient should not take this medicine unless the doctor considers it absolutely necessary.

If treatment is necessary during this period or during attempts to conceive, the lowest possible dose should be used for the shortest possible time.

From the 20th week of pregnancy, Axoprofen Forte may cause kidney problems in the unborn baby if taken for more than a few days (this can lead to low levels of amniotic fluid surrounding the baby or narrowing of the arterial duct in the baby's heart).

If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in small amounts and is unlikely to affect the baby, especially if taken for a short time.

Fertility

Ibuprofen belongs to a group of medicines (NSAIDs) that may impair female fertility.

This effect is reversible after stopping the medicine.

It is unlikely that this medicine, when taken occasionally, will affect fertility, but before taking the medicine, the patient should inform the doctor if she has problems getting pregnant.

Driving and using machines

There is no data on the effect of Axoprofen Forte on the ability to drive and use machines.

Axoprofen Forte contains sorbitol 70%

The medicine contains 40 mg of sorbitol 70% in each 1 ml of oral suspension.

Sorbitol is a source of fructose.

If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, consult a doctor before taking the medicine or giving it to a child.

Axoprofen Forte contains propylene glycol

The medicine contains 10 mg of propylene glycol in each 1 ml of oral suspension.

Axoprofen Forte contains sodium benzoate (E 211)

The medicine contains 2 mg of sodium benzoate (E 211) in each 1 ml of oral suspension.

Axoprofen Forte contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Axoprofen Forte

Take this medicine always exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

In case of doubt, consult a doctor, pharmacist, or nurse.

The medicine is intended for short-term use.

Use the smallest effective dose for the shortest possible time necessary to relieve symptoms.

If the symptoms persist or worsen during an infection, consult a doctor immediately (see section 2).

The dosage of the medicine may vary depending on the patient, their age, and the disease.

Each 5 ml of suspension contains 200 mg of ibuprofen.

The medicine does not contain sugar, so it can be taken by patients with diabetes.

Shake the bottle well before use.

Use in children and adolescents

Axoprofen Forte is not recommended for children under 3 months old or weighing less than 5 kg due to insufficient data on its use in this age group.

Children under 6 months old should only be given the medicine after consulting a doctor.

Do not use in children from 3 to 6 months old for more than 24 hours.

If symptoms worsen or do not improve after 24 hours of taking the medicine, consult a doctor.

Do not use in children over 6 months old for more than 3 days.

If symptoms worsen or do not improve after 3 days of taking the medicine, consult a doctor.

Do not exceed the recommended dose of the medicine.

The recommended daily dose of the medicine is 20 to 30 mg/kg of body weight, given in 3 or 4 divided doses.

There should be at least 6 hours between doses.

• Infants from 3 to 6 months old (weighing over 5 kg): 1.25 ml (50 mg of ibuprofen) - 3 times a day.
• Infants from 6 to 12 months old (weighing 7-9 kg): 1.25 ml (50 mg of ibuprofen) - 3-4 times a day.
• Children from 1 to 3 years old (weighing 10-15 kg): 2.5 ml (100 mg of ibuprofen) - 3 times a day.
• Children from 4 to 6 years old (weighing 16-20 kg): 3.75 ml (150 mg of ibuprofen) - 3 times a day.
• Children from 7 to 9 years old (weighing 21-29 kg): 5 ml (200 mg of ibuprofen) - 3 times a day.
• Children from 10 to 12 years old (weighing 30-40 kg): 7.5 ml (300 mg of ibuprofen) - 3 times a day.
• Adolescents over 12 years old (weighing over 40 kg): 7.5 ml (300 mg of ibuprofen) - 3-4 times a day.

Use in adults

For adult patients, it is recommended to use other forms of ibuprofen in doses of 200 mg, 400 mg, or 600 mg.

However, in case of swallowing problems, the medicine in the form of a suspension can be given 4 times a day at a dose of 7.5 ml (corresponding to 300 mg of ibuprofen).

For adult patients and adolescents, the maximum recommended dose is 1200 mg per day.

If it is necessary to take the medicine for more than 3 days to reduce fever or more than 4 days to treat pain, or if the patient's condition worsens, consult a doctor.

Elderly patients

There is no need to adjust the dose, except in cases of kidney or liver failure.

In such cases, the dose should be determined individually.

If symptoms do not improve or worsen, consult a doctor.

Use the smallest effective dose for the shortest possible time necessary to relieve symptoms.

Do not exceed the recommended dose of the medicine.

A measuring spoon or a dosing syringe with a capacity of 5 ml and a scale to facilitate dosing is attached to the packaging.

Taking a higher dose of Axoprofen Forte than recommended

If you have taken a higher dose of Axoprofen Forte than recommended or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus.

It may also cause agitation, drowsiness, disorientation, or coma.

Seizures have occasionally occurred in patients.

After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred.

Blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have also occurred.

In addition, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating clotting factors.

Acute kidney failure and liver damage may occur.

In asthmatics, asthma may worsen.

Additionally, low blood pressure and breathing difficulties may occur.

Missing a dose of Axoprofen Forte

Do not take a double dose to make up for a missed dose.

If you miss a dose, take the next dose as needed, provided that the last dose was taken at least 4 hours earlier.

If you have any questions or doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Axoprofen Forte can cause side effects, although not everybody gets them.

Medicines like Axoprofen Forte may increase the risk of heart attack (myocardial infarction) or stroke.

Fluid retention (edema), high blood pressure, and heart failure have been observed with the use of NSAIDs.

If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

• Red, non-raised, target-like or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Very rare(occurring in less than 1 in 10,000 patients):

• blood in the stool or black, tarry stools;
• bloody vomiting or vomiting containing particles resembling coffee grounds;
• severe allergic reactions with symptoms such as: swelling of the face, tongue, throat, or larynx, difficulty breathing, rapid heartbeat, fainting, dizziness, or loss of consciousness;
• wheezing (asthma), worsening of asthma, difficulty breathing;
• symptoms of meningitis, such as: stiffness of the neck, fever, disorientation, headache, nausea, vomiting. The risk of meningitis is increased in patients with existing autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disease;
• severe skin reactions, which may include peeling, blisters, and skin damage;
• worsening of existing severe skin infections;
• infections associated with conditions for which NSAIDs are used (e.g. occurrence of necrotizing fasciitis). If symptoms of infection occur or worsen while taking ibuprofen, the patient should immediately consult a doctor;
• stomach and duodenal ulcers, as well as gastrointestinal bleeding;
• kidney diseases, which can lead to kidney failure (the patient may urinate more or less, there may be blood in the urine, or the urine may be cloudy, shortness of breath, weakness, and fatigue, loss of appetite, swollen ankles);
• high blood pressure, heart failure (the patient may be overly tired, have difficulty breathing, or have swollen legs).

Frequency not known(frequency cannot be determined from available data):

• severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include: widespread skin rash, high body temperature, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell);
• red, peeling, blistering skin rash, usually on the folds of the skin, torso, and upper limbs, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Axoprofen Forte and seek medical attention immediately. See also section 2;
• severe skin and soft tissue infections as complications of chickenpox
• skin becomes sensitive to light.

In addition, if you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

Uncommon(occurring in 1 in 1,000 to 1 in 100 patients):

• allergic skin reactions, such as: itching, hives (red rash);
• vision disturbances;
• stomach pain, indigestion, nausea.

Rare(occurring in 1 in 10,000 patients):

• dizziness, insomnia, agitation, irritability, fatigue;
• optic neuritis;
• vomiting.

Very rare(occurring in less than 1 in 10,000 patients):

• jaundice or yellowing of the eyes, pale stools, or abdominal pain (these symptoms may be caused by liver function disorders);
• fatigue, unexplained bruising or bleeding, sore throat, mouth ulcers, flu-like symptoms, including fever. This may be due to changes in blood morphology.

Other possible side effects:

Common(affecting 1 in 100 to 1 in 10 patients):

• fatigue.

Uncommon(affecting 1 in 1,000 to 1 in 100 patients):

• headache.

Rare(affecting 1 in 10,000 patients):

• edema, diarrhea, bloating, constipation. Consult a doctor if bloating persists for more than a few days and is troublesome.

Very rare(affecting less than 1 in 10,000 patients):

• worsening of ulcerative colitis and Crohn's disease;
• swelling or ulcers of the oral mucosa.

Frequency not known(frequency cannot be determined from available data):

• fluid retention, which can cause swelling of the limbs;
• high blood pressure;
• increased risk of heart attack or stroke (may be caused by long-term use of ibuprofen in high doses). At the dose level given to children, the likelihood of these side effects is small
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Axoprofen Forte

Do not store above 25°C. Store in the original packaging to protect from light.

Keep the medicine out of sight and reach of children.

Shake well before use.

After opening the bottle, the medicine should be used within 3 months.

Do not use this medicine after the expiry date stated on the label and carton after EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What Axoprofen Forte contains

• The active substance of the medicine is ibuprofen. Each 5 ml of oral suspension contains 200 mg of ibuprofen.
• The other ingredients are: propylene glycol, citric acid anhydrous, sodium benzoate (E 211), sodium saccharin, sodium citrate, sorbitol 70%, glycerol, xanthan gum, polysorbate 80, orange flavor, purified water.

What Axoprofen Forte looks like and what the packaging contains

Axoprofen Forte is a white or almost white, homogeneous suspension with an orange flavor.

Packaging:

A 100 ml bottle made of orange glass type III, with a child-resistant cap made of polyethylene and polypropylene (HDPE/PPH/LDPE), with a measuring spoon made of polypropylene (PP) with a capacity of 5 ml and a scale to facilitate dosing, in a cardboard box.

Marketing authorization holder

Aristo Pharma Sp. z o.o.

ul. Baletowa 30

02-867 Warsaw

tel: +48 22 855 40 93

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

Date of last revision of the leaflet:

3. How to Take Axoprofen Forte

This medication should always be taken exactly as described in this patient information leaflet or as directed by the doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse. The medication is intended for short-term use. The patient should take the smallest effective dose for the shortest possible time necessary to relieve symptoms. If the patient has an infection and symptoms such as fever and pain persist or worsen, they should consult their doctor immediately (see section 2). The dosage of the medication may vary depending on the patient, their age, and the condition being treated. Each 5 ml of suspension contains 200 mg of ibuprofen. The medication does not contain sugar, so it can be taken by patients with diabetes. Before use, the bottle should be shaken well.

Use in Children and Adolescents

Axoprofen Forte should not be given to children under 3 months of age or weighing less than 5 kg, as there is insufficient data on its use in this age group. Children under 6 months of age should only be given the medication after consulting a doctor. The medication should not be used in children aged 3 to 6 months for more than 24 hours. If symptoms worsen or do not improve after 24 hours of treatment, the patient should consult their doctor. The medication should not be used in children over 6 months of age for more than 3 days. If symptoms worsen or do not improve after 3 days of treatment, the patient should consult their doctor. The patient should not exceed the recommended dose. The recommended daily dose is 20 to 30 mg/kg of body weight, given in 3 or 4 divided doses. There should be at least a 6-hour interval between doses.

• Infants aged 3 to 6 months (weighing over 5 kg): 1.25 ml (50 mg of ibuprofen) - 3 times a day.
• Infants aged 6 to 12 months (weighing 7-9 kg): 1.25 ml (50 mg of ibuprofen) - 3-4 times a day.
• Children aged 1 to 3 years (weighing 10-15 kg): 2.5 ml (100 mg of ibuprofen) - 3 times a day.
• Children aged 4 to 6 years (weighing 16-20 kg): 3.75 ml (150 mg of ibuprofen) - 3 times a day.
• Children aged 7 to 9 years (weighing 21-29 kg): 5 ml (200 mg of ibuprofen) - 3 times a day.
• Children aged 10 to 12 years (weighing 30-40 kg): 7.5 ml (300 mg of ibuprofen) - 3 times a day.
• Adolescents over 12 years of age (weighing over 40 kg): 7.5 ml (300 mg of ibuprofen) - 3-4 times a day.

Use in Adults

For adult patients, it is recommended to use other ibuprofen formulations in doses of 200 mg, 400 mg, or 600 mg. However, in cases of swallowing difficulties, the suspension can be given 4 times a day at a dose of 7.5 ml (equivalent to 300 mg of ibuprofen). For adult patients and adolescents, the maximum recommended dose is 1200 mg per day. If it is necessary to use the medication for more than 3 days to reduce fever or for more than 4 days to treat pain, or if the patient's condition worsens, they should consult their doctor. Elderly Patients
There is no need to adjust the dosage, except in cases of renal or hepatic impairment. In such cases, the dose should be determined individually. If symptoms do not improve or worsen, the patient should consult their doctor. The patient should take the smallest effective dose for the shortest possible time necessary to relieve symptoms. The patient should not exceed the recommended dose. A measuring spoon or a 5 ml oral syringe with a scale to facilitate dosing is included with the packaging. Instructions for using Axoprofen Forte with an oral syringe:

• 1. Before use, shake the bottle well to mix its contents.
• 2. Unscrew the bottle cap (press down and turn in the opposite direction of the arrow - as shown on the cap).
• 3. Insert the syringe firmly into the bottle opening.
• 4. To fill the syringe, turn the bottle upside down and then carefully push the syringe plunger down, drawing the suspension up to the desired mark on the syringe.
• 5. Turn the bottle back to its original position and carefully remove the syringe from the bottle.
• 6. Place the syringe tip in the patient's mouth and, pressing the plunger slowly, carefully empty the contents of the syringe.
• 7. If the dose to be given is greater than 5 ml, repeat steps 2 to 6 to administer the correct amount of medication.
• 8. After use, close the bottle by screwing the cap back on and wash and dry the syringe.

Taking a Higher Than Recommended Dose of Axoprofen Forte

If the patient has taken a higher dose of Axoprofen Forte than recommended or if a child has accidentally taken the medication, they should always consult their doctor or go to the nearest hospital to get an opinion on the potential health risk and advice on what actions to take. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. The patient may also experience excitement, drowsiness, disorientation, or coma. Seizures have occurred rarely in patients. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, the prothrombin time/INR may be prolonged, likely due to the disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and difficulty breathing may occur.

Missing a Dose of Axoprofen Forte

The patient should not take a double dose to make up for a missed dose. If a dose is missed, the next dose should be taken as needed, provided that the last dose was taken at least 4 hours earlier. If the patient has any questions or concerns about taking this medication, they should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Axoprofen Forte can cause side effects, although not everyone will experience them. Medications like Axoprofen Forte may slightly increase the risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), increased blood pressure, and heart failure have been observed in association with the use of NSAIDs. If the patient experiences any of the following serious side effects, they should stop taking the medication and consult their doctor immediately:

If the patient experiences any of the following serious side effects, they should stop taking the medication and consult their doctor immediately:

• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Very Rarely(occurring in fewer than 1 in 10,000 patients):

• presence of blood in stool or black, tarry stools;
• bloody vomiting or vomiting containing coffee ground-like material;
• severe allergic reactions manifesting as: swelling of the face, tongue, throat, or neck,

difficulty breathing, rapid heartbeat, fainting, dizziness, or collapse;

• wheezing (asthma), worsening of asthma, difficulty breathing;
• symptoms of meningitis, such as: stiffness of the neck, fever, disorientation, headache, nausea, vomiting. The risk of meningitis is increased in patients with existing autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disease;
• severe allergic skin reactions that can include: peeling, blisters, and skin damage;
• worsening of existing severe skin infections;
• infections related to conditions that are the reason for using NSAIDs (e.g., occurrence of necrotizing fasciitis). If symptoms of infection worsen or appear while taking ibuprofen, the patient should immediately consult their doctor;
• stomach and duodenal ulcers and gastrointestinal bleeding;
• kidney diseases that can lead to kidney failure (the patient may urinate more or less, may have blood in their urine, or their urine may be cloudy, may have shortness of breath, is weak and tired, has no appetite, and has swollen ankles);
• high blood pressure, heart failure (the patient may be overly tired, have difficulty breathing, or have swollen legs).

Frequency Not Known(frequency cannot be estimated from the available data):

• severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include: widespread skin rash, high body temperature, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell);
• a red, peeling rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Axoprofen Forte and seek immediate medical attention. See also section 2;
• severe skin and soft tissue infections as complications of chickenpox;
• skin becomes sensitive to light.

If the patient experiences any of the following serious side effects, they should stop taking the medication and consult their doctor immediately:

Uncommon(occurring in 1 to 10 in 1,000 patients)

• allergic skin reactions, such as: itching, hives (red rash);
• vision disturbances;
• stomach pain, indigestion, nausea.

Rare(occurring in 1 to 10 in 10,000 patients)

• dizziness, insomnia, excitement, irritability, feeling of fatigue;
• optic neuritis;
• vomiting.

Very Rare(occurring in fewer than 1 in 10,000 patients)

• yellowing of the skin or eyes, pale stools, or abdominal pain (these symptoms may be caused by liver function disorders);
• fatigue, unusual bruising or unexplained bleeding, sore throat, mouth ulcers, flu-like symptoms, including fever. This may be due to changes in blood morphology.

Other Possible Side Effects:

Common(affecting 1 to 10 in 100 patients)

• feeling of fatigue.

Uncommon(affecting 1 to 10 in 1,000 patients)

• headache.

Rare(affecting 1 to 10 in 10,000 patients)

• edema, diarrhea, bloating, constipation. The patient should consult their doctor if bloating persists for more than a few days and is bothersome.

Very Rare(affecting fewer than 1 in 10,000 patients)

• worsening of colitis and Crohn's disease;
• swelling or ulcers of the mouth mucosa.

Frequency Not Known(frequency cannot be estimated from the available data)

• fluid retention, which can cause swelling of the limbs;
• high blood pressure;
• increased risk of heart attack or stroke (may be caused by long-term use of ibuprofen in high doses). At the dose level given to children, the likelihood of these side effects is low;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Axoprofen Forte

Do not store above 25°C. Store in the original packaging to protect from light. The medication should be stored out of sight and reach of children. Before use, shake the bottle well. After opening the bottle for the first time, the medication should be used within 3 months. Do not use this medication after the expiration date stated on the label and carton after EXP. The expiration date refers to the last day of the given month. Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Axoprofen Forte Contains

• The active substance of the medication is ibuprofen. Each 5 ml of oral suspension contains 200 mg of ibuprofen.
• Other ingredients are: propylene glycol, anhydrous citric acid, sodium benzoate (E 211), sodium saccharin, sodium citrate, sorbitol 70%, glycerol, xanthan gum, polysorbate 80, orange flavor, purified water.

What Axoprofen Forte Looks Like and What the Package Contains

Axoprofen Forte is a white or almost white, homogeneous suspension with an orange flavor. The packaging includes: a 100 ml or 200 ml bottle made of orange glass type III, with a polypropylene (PP) cap that is child-resistant with a polyethylene (LDPE) connector, and a 5 ml oral syringe made of polypropylene/polyethylene (HDPE) with a scale, in a cardboard box.

Marketing Authorization Holder

Aristo Pharma Sp. z o.o. Baletowa 30, 02-867 Warsaw, tel: +48 22 855 40 93

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A. Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16, 3450-232 Mortágua, Portugal Date of last revision of the leaflet: